在可变的观察和随机试验中区分药物释放支架的晚期光量损失的稳定性
Laura Mauri1, E John Orav, Susana C Candia
1Brigham and Women's Hospital, Boston, MA 02116, USA. lmauri1@partners.org
Circulation
|November 4, 2005
概括
平均静脉支架延迟损失是评估跨研究支架性能的更可靠的指标,而不是恢复率. 这一指标可以更好地区分释放药物的支架平台,有助于早期评估.
科学领域:
- 心血管研究研究心血管研究
- 医疗器械技术 医疗器械技术
- 临床试验方法论 临床试验方法论
背景情况:
- 在支架试验中,由于病例组合的差异,缩症的发生率有所不同.
- 提议使用静脉支架的晚期损失作为一种更稳定的复原倾向估计器.
研究的目的:
- 为了评估平均内置支架晚损失是否是一个比二元复原率更可靠的指标,以便在不同研究中比较支架性能.
- 在早期研究中确定最佳的终点来评估药物释放支架.
主要方法:
- 分析了46项涉及药物排泄和裸金属支架的试验.
- 对于晚期损失和目标损伤再血管化 (TLR) 的类内相关系数 (rho) 的比较.
- 基于糖尿病患病率和病变长度的晚期损失的标准化.
主要成果:
- 增加的平均晚期损失与更高的目标损伤再血管化 (TLR) 率相关 (P<0.001).
- 晚期损失表明,与TLR相比,在支架类别 (药物排泄与裸金属) 之间有更好的区别 (rho=0.71与0.22).
- 晚期损失也显示了个体支架比较的更好的歧视 (rho=0.68对比0.19).
结论:
- 平均静脉静脉延迟损失比二元静脉复缩率更可靠,用于区分静脉复缩倾向在静脉支架平台之间.
- 在早期的非随机研究中,迟损失可能是评估药物释放支架的最佳终点.
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